Medtronic Model 2409 Implantable Pacemaker Pulse-Generator
FDA 510(k)Class III (US FDA 510(k))
Identifiers
- 510(k) Number
- K812580 FDA 510(k)
- FDA Product Code
- DXY FDA 510(k)
Classification
- Device Class
- Class III FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.3610 FDA 510(k)
- Regulation Number
- 870.3610 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Medtronic Model 2409 is an implantable pacemaker pulse-generator, a Class III medical device designed to regulate heart rhythm by delivering electrical impulses to the heart when necessary. It is intended for patients with bradycardia or other cardiac conduction disorders requiring consistent pacing support.
This device is supplied sterile and intended for single-use implantation by qualified healthcare professionals in clinical settings. It is regulated under FDA 510(k) clearance (K812580, K800226) and falls under product code DXY, adhering to cardiovascular device standards. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.
Frequently asked questions
What is the primary clinical purpose of the Medtronic Model 2409 implantable pacemaker pulse-generator, and who is it designed for?
The Medtronic Model 2409 is designed to regulate heart rhythm by delivering electrical impulses to the heart when necessary. It is specifically intended for patients with bradycardia or other cardiac conduction disorders requiring consistent pacing support. This device is meant for single-use implantation by qualified healthcare professionals in clinical settings.
How is the Medtronic Model 2409 supplied, and what precautions should be taken during handling?
The Medtronic Model 2409 is supplied sterile, ensuring it is ready for immediate use in a clinical setting. Since it is intended for single-use implantation, it must be handled with care to maintain sterility and functionality. Always follow the manufacturer’s guidelines for storage and handling to avoid contamination or damage.
Is the Medtronic Model 2409 reusable, or is it meant for one-time use after implantation?
The Medtronic Model 2409 is explicitly intended for single-use implantation. Once implanted, it is not designed to be removed or reused, aligning with standard practices for implantable pacemaker pulse-generators to ensure patient safety and device reliability.
What regulatory pathway does the Medtronic Model 2409 follow, and what does this mean for its use in clinical settings?
The Medtronic Model 2409 is regulated under the FDA’s 510(k) clearance pathway, with specific clearance numbers (e.g., K812580, K800226) and classified as a Class III medical device. This means it has undergone rigorous review by the FDA to ensure safety and effectiveness before being authorized for use in clinical settings. The product code DXY further categorizes it under cardiovascular devices, confirming its specialized medical purpose.
What storage requirements should be followed to ensure the Medtronic Model 2409 remains functional and sterile before use?
The Medtronic Model 2409 must be stored according to the manufacturer’s guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, proper storage conditions—such as temperature, humidity, and packaging integrity—are critical. Failure to adhere to these guidelines could compromise the device’s performance or sterility, risking patient safety during implantation.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Medtronic Vascular 2409 - allmed.wiki, K812580 FDA 510(k) - MEDTRONIC MODEL 2409 | Medtronic Vascular, K800226 FDA 510(k) - MEDTRONIC MODEL 2409 | Medtronic Vascular
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K812580 | Class III | Active |
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Manufacturer
- Manufacturer
- Medtronic Vascular
Sources (1)
- FDA 510(k) K812580 24 fields · synced Oct 6, 2026